Pharma Frontiers: Daily Digest of Global Pharmaceutical News – Sep 4

1.Buchang Pharmaceuticals Submits Long-Acting EPO Product for Market Approval

On September 3, the CDE website indicated that Buchang Pharmaceuticals has submitted a market application for its EPO-Fc fusion protein, Epai Epoetin Alpha (rhEPO-Fc), intended for the treatment of anemia in chronic kidney disease. Epai Epoetin Alpha is a long-acting erythropoiesis-stimulating agent (ESA) developed by Buchang Pharmaceuticals. In March 2021, Buchang Pharmaceuticals initiated a Phase III study comparing Epai Epoetin Alpha with recombinant EPO Epoetin Alfa for maintenance treatment in chronic kidney disease patients undergoing hemodialysis. This study was completed in June 2023, though the results have not yet been disclosed. Currently, there are seven EPO drugs available globally.

2.Hybio Pharmaceutical Initiates Phase III Clinical Trial for Semaglutide Biosimilar in Obesity

On September 3, the CDE website showed that Hybio Pharmaceutical has initiated a Phase III clinical trial to compare the efficacy and safety of HY310 with Semaglutide over a 44-week treatment period in obese patients. On May 27 of this year, Hybio Pharmaceutical entered into a partnership with Sunshine Mandi to co-develop, exclusively supply/procure, and share sales revenue for Semaglutide injection (indicated for weight loss). In the area of weight management, Semaglutide was approved in the U.S. in June 2021 for long-term weight management, with clinical trials showing that obese patients who continued treatment achieved an average weight reduction of 17%-18% after 68 weeks. In June 2024, Wegovy was approved in China for long-term weight management in adults, in conjunction with dietary control and increased physical activity, with specific initial body mass index (BMI) criteria.

3.Multitude Therapeutics' CDH17-Targeting ADC Receives Clinical Trial Approval

Recently, Multitude Therapeutics' Class 1 new drug, AMT-676, was granted implied consent for clinical trials in China for the treatment of advanced solid tumors. According to public information, AMT-676 is a CDH17-targeting antibody-drug conjugate (ADC) developed by Multitude Therapeutics. A Phase I clinical trial for advanced solid tumors has already been initiated in Australia. CDH17 is overexpressed in tumor tissues such as those of the stomach, pancreas, liver, esophagus, bile ducts, and colorectal cancer. It is considered a promising target for drug development in gastrointestinal tumors, and several pharmaceutical companies worldwide have already developed new drugs targeting CDH17.

4.CSPC Pharmaceutical's FIC Drug ALMB-0168 Receives Clinical Application Acceptance by CDE

On September 2, the CDE announced that the clinical application for ALMB-0168 injection, a Class 1 new drug submitted by Enlemai Biotechnology, a subsidiary of CSPC Pharmaceutical, has been accepted. ALMB-0168 is a first-in-class (FIC) humanized monoclonal antibody agonist targeting the novel half-channel membrane protein Connexin43 (Cx43). It is intended for the treatment of major clinical conditions such as bone cancer, cancer bone metastasis, and osteoporosis. The Cx43 half-channel is considered a key regulator of bone homeostasis and a new target for bone cancer. Preclinical studies have shown that ALMB-0168 can inhibit bone cancer and breast cancer bone metastasis. In 2019, the drug was granted Orphan Drug Designation and Rare Pediatric Disease Designation by the U.S. FDA for the treatment of bone cancer.

5.Simcere's New Stroke Drug Receives FDA Breakthrough Therapy Designation

On September 2, Simcere Pharmaceutical announced that its innovative stroke drug Edaravone/Dexborneol, co-developed with Ningdan New Drug, has been granted "Breakthrough Therapy Designation" by the U.S. FDA for the treatment of acute ischemic stroke (AIS). According to the press release, Edaravone/Dexborneol is the first drug in the global stroke treatment field to receive this designation from the FDA. Edaravone/Dexborneol is a neuroprotective agent that contains two active ingredients, Edaravone and Decanol, which have antioxidant, anti-inflammatory, and synergistic effects, significantly reducing brain cell damage caused by AIS. The drug's unique sublingual tablet formulation rapidly disintegrates upon contact with saliva under the tongue, allowing for quick absorption into the bloodstream through the sublingual venous plexus, potentially increasing the flexibility of stroke treatment options.

6.Arrowhead/Visirna's Quarterly Injection for Potent Lipid-Lowering to Submit for Approval by Year-End

On September 2, Arrowhead Pharmaceuticals announced the results of the Phase III PALISADE study of Plozasiran in patients with familial chylomicronemia syndrome (FCS), demonstrating that the trial successfully met its primary endpoint and all key secondary endpoints with multiple controls, including statistically significant reductions in triglycerides (TGs), apolipoprotein C-III (APOC3), and the incidence of acute pancreatitis (AP). Based on the positive results from the PALISADE study, Arrowhead plans to submit a New Drug Application (NDA) to the U.S. FDA by the end of 2024 and subsequently seek regulatory approval from other global agencies. The drug has already received Orphan Drug Designation and Fast Track Designation from the FDA, as well as Orphan Drug Designation from the EMA. Currently, Visirna holds the rights to Plozasiran in the Greater China region, where a Phase III clinical trial targeting Chinese adult FCS patients is underway, with full patient enrollment completed in early 2024.

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